EMA’s continuous straining efforts to develop & improve biosimilar medicine has been ongoing for decades now. While still maintaining the strict European Union safety standards with the aim to improve access to biosimilar drugs in Europe, making it one of the top places for biosimilar drugs growth.

A biosimilar is a biological medicine that closely resembles an existing approved biological drug, known as the reference medicine. These therapies play a key role in enhancing patient access to important treatments for conditions such as cancer, rheumatoid arthritis, and inflammatory bowel disease. Biosimilars deliver the same clinical effectiveness and safety as their reference medicines. Hence such medical development will enhance market competition thereby increasing patient access to life critical medications.

The approval of biosimilars is based on a thorough evaluation process that includes comparative & clinical studies with the reference medicine in order to ensure clinical efficacy & safety of the biosimilar product.

With growing experience and better testing methods, the draft reflection paper suggests that showing similarity in structure, function, and how the body processes the medicine may be enough to approve a biosimilar. This could reduce the need for large clinical studies, making development easier while still ensuring safety and effectiveness, and helping more patients in the EU access these medicines.

Learn more: Streamlining development and assessment of biosimilar medicines | European Medicines Agency (EMA)